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Amgen Announces Positive Top-Line Results From Phase 3 Study Of Prolia (Denosumab) In Patients Receiving Glucocorticoid Therapy
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Results from the glucocorticoid-induced osteoporosis (GIOP) study showed that, in patients receiving continuing glucocorticoid therapy, Prolia treatment led to greater gains in BMD, compared with risedronate, both at the lumbar spine (4.4 percent vs. 2.3 percent, respectively) and total hip (2.1 percent vs. 0.6 percent, respectively). Similarly, in patients newly initiating glucocorticoid therapy, Prolia treatment led to greater increases in BMD, compared with risedronate, both at the lumbar spine (3.8 percent vs. 0.8 percent, respectively) and total hip (1.7 percent vs. 0.2 percent, respectively).Adverse events (AEs) and serious adverse events (SAEs) were similar across treatment groups and consistent with the known safety profile of Prolia. No SAEs were reported with a subject incidence of two percent or greater in either treatment group. This is a Phase 3 international, multi-center, randomized, double-blind, double-dummy, active-controlled, parallel-group study in men and women receiving oral glucocorticoid therapy. A total of 795 patients were enrolled in the 24-month study to evaluate the safety and efficacy of treatment with Prolia 60 mg subcutaneously every six months compared with oral risedronate 5 mg daily in two patient subpopulations: 505 patients receiving continuing glucocorticoid therapy (defined as patients receiving greater than or equal to 7.5 mg daily prednisone or its equivalent for three months or longer and planning to continue treatment for a total of at least six months) and 290 patients newly initiating glucocorticoid therapy (defined as patients receiving greater than or equal to 7.5 mg daily prednisone or its equivalent for less than three months and who are planning to continue treatment for a total of at least six months).Evaluation of the primary endpoint (the percent change from baseline in lumbar spine BMD at 12 months, assessing non-inferiority) and two secondary endpoints assessed at 12 months (the percent change from baseline in lumbar spine and total hip BMD, assessing superiority) was conducted; further analysis of these results is ongoing and will be submitted to a future medical conference and for publication. The study remains double-blinded and ongoing for an additional 12 months.
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Aug 29, 2016
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Related Keywords Prolia, Denosumab, Glucocorticoid Therapy